UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017990 |
|---|---|
| Receipt number | R000020847 |
| Scientific Title | Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2023/12/30 21:51:40 |
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Basic information
Public title
Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system
Acronym
The usefulness of LCI for endoscopic diagnosis of inflammatory bowel disease
Scientific Title
Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system
Scientific Title:Acronym
The usefulness of LCI for endoscopic diagnosis of inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Mucosal healing and control of intestinal mucosal inflammation have been reported as important treatment goals for maintaining clinical remission in ulcerative colitis (UC) and Crohn's disease (CD) patients. In this study, we investigated the availability and efficacy of linked color imaging (LCI), a novel endoscopic enhancement system, for the diagnosis of mucosal inflammation in UC and CD patients. Besides, we investigate the usefulness for prediction of prognosis for UC and CD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Correlation between LCI findings, digitization of LCI and intestinal mucosal inflammation, cytokine mRNA expression.
Key secondary outcomes
Correlation between LCI findings, digitization of LCI and prognosis of UC and CD.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients diagnosed as ulcerative colitis and Crohn's disease based on the criteria of Japanese Ministry of Health, Specific disease intractable inflammation-related intestinal tract disorder research group.
Key exclusion criteria
a) Re-registration example to the examination
b) The patients with malignant tumor
c) The patients with surgical operation within 12 weeks
d) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL
075-251-5519
takatomo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Uchiyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kyoto Prefectural University of Medicine, Kyoto Prefectural University of Medicine
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The image enhancement system used in this study is Fujifilm's new endoscopic image enhancement system, which is a signal processing system for images taken in BLI-bright mode of Fujifilm's LASEREO, which irradiates a mixture of narrow-band light and white light (Linked Color Imaging: LCI). In addition, the degree of redness is analyzed by the distribution of pigments in the L*a*b* system, and by quantifying the a* value which is a component of red, we attempt to objectively express the inflammation of mucosal tissue and endoscopic score.
Biopsies from each site taken in LCI mode (four for histological diagnosis, immunostaining, protein analysis, and mRNA expression analysis in the ileum, sigmoid colon, and rectum, and only one for histopathological diagnosis in other sites).
As for protein and mRNA expression in the biopsy tissues, mRNA and protein expression of genes that have been reported to be related to the pathogenesis of IBD (genes related to the pathogenesis of inflammation, proliferation and re-epithelialization of epithelial cells): cytokines, growth factors, short-chain fatty acid receptors, Wnt-related genes, factors related to inflammation and tissue repair such as VEGF, and microRNAs. Protein expression will be examined by Western blotting or ELISA, and mRNA expression will be examined by real time PCR. The above factors will also be confirmed by immunostaining and in situ hybridization to determine the expression cells. Some of the biopsied tissues will be sequenced for RNA expression by Next Generation Sequencing (NGS) to examine the details of RNA expression and the interrelationship of cytokines and other factors. To predict the long-term prognosis, endoscopy will be performed every year from the time of the initial measurement for up to 8 years, and the same study as above will be performed at that time.
Management information
Registered date
| 2015 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020847
